Ohm , IMO , this approval will never wait for 48 p
Post# of 154881
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Posted On: 12/22/2019 8:46:54 AM
Ohm , IMO , this approval will never wait for 48 patients , but they may have more as Dr NP said that in compassionate trial they testing about 20 patients considering treatment at present time .
They were talking interim results 3-4 months but I think this changed now since patient so far showing significant improvements within few weeks ..
I don’t think there is a reason to wait much longer then couple of months before presenting to FDA..
—3 patients they planning to ask for BTD
—10-12 patients according to Dr NP statement they be asking for approval .
So imo if more patients with improvement as patient number 1 , medicine should be approved in 2020 for cancers , not sure if TNBC or basket , depends what types of cancers they will have patients in compassionate trial ,, they may not call that officially basket trial but since they accept patients with many different metastatic cancers for compassionate treatment , it is ,
All this if results as good or close to our first patient .
And I be very surprise if with all this in cancer , and approved combo , pps will be only 6-7 this year ..
As always imo ..
They were talking interim results 3-4 months but I think this changed now since patient so far showing significant improvements within few weeks ..
I don’t think there is a reason to wait much longer then couple of months before presenting to FDA..
—3 patients they planning to ask for BTD
—10-12 patients according to Dr NP statement they be asking for approval .
So imo if more patients with improvement as patient number 1 , medicine should be approved in 2020 for cancers , not sure if TNBC or basket , depends what types of cancers they will have patients in compassionate trial ,, they may not call that officially basket trial but since they accept patients with many different metastatic cancers for compassionate treatment , it is ,
All this if results as good or close to our first patient .
And I be very surprise if with all this in cancer , and approved combo , pps will be only 6-7 this year ..
As always imo ..
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